Quality Management System for Clinical Diagnostics

CAP Accreditation

The CAP(College of American Pathologists) Laboratory Accreditation Program begun in 1961 which is internationally recognized and the largest of its kind, accrediting more than 8,000 laboratories. The CAP inspects and accredits medical laboratories under authority from CMS(the Centers for Medicare & Medicaid Services). The U.S. federal government recognizes the CAP accreditation as being equal-to or more stringent-than the government’s own inspection program. In order to receive CAP accreditation, a laboratory must demonstrate that it operates with the highest standards of quality, accuracy and consistency. The CAP inspection process investigates several components of the laboratory.

Macrogen’s headquarters, Bundang Precision Medicine Center, and Psomagen(Macrogen USA) have met the highest standards of the inspection process. Also, it has been awarded the CAP accreditation for clinical diagnostic sequencing using NGS technology.

CLIA Certification

The CLIA(Clinical Laboratory Improvement Amendments) is a US certification standard that verifies the accuracy, reliability, and propriety of tests performed on specimens from human for the purpose of the diagnostics, prevention and treatment of diseases.

Macrogen received CLIA certification for its headquarters, Bundang Precision Medicine Center and Psomagen(Macrogen USA) to enter the domestic and overseas clinical diagnostics market. With CLIA certification, Macrogen provides various clinical diagnostics services as well as inspections of patients specimens.

GCLP Accreditation

The GCLP(Good Clinical Laboratory Practice) is a quality standard for laboratories that analyze blood and urine samples for clinical trials. By law in Korea, only an institution that meets certain requirements in terms of facilities and manpower can be GCLP accredited and assigned as an official test institution by the Minister of the MFDS. The MFDS has made it mandatory for any clinical trial sample analyses, conducted after 25th of October 2018, must be conducted by a GCLP accredited test institute, authorized by the MFDS.

With its new designation, Macrogen will be able to perform NGS (Next Generation Sequencing) analysis of clinical trial samples. Currently, Macrogen is the first and only GCLP accredited institute that can provide a reliable analysis service using NGS technology and strengthen the competitiveness of the Korean clinical trial market.

GMP Accreditation

GMP (Good Manufacturing Practice, Medical device manufacture and quality control standards) is the system accredited by the Ministry of Food and Drug Safety for consumer safety. It is a quality control standard that ensures manufacture and supply of high quality medical product, by applying to the entire process of the manufacture, from raw material purchase, manufacture, packaging, storage and shipment, as well as the structure of the facility.

In February 2019, Macrogen received [NGS-based in vitro diagnostic reagent GMP] from the Ministry of Food and Drug Safety confirming the stability and effectiveness of in vitro diagnostic reagent manufacturing technology. With the accreditation, Macrogen can launch and sell its own clinical diagnostic product directly to the market.

Genetic Testing Accuracy Evaluation Certification

As genetic testing for medical and research purposes became more commonplace, the Genetic Testing Accuracy Evaluation Certification was created to assess the accuracy of testing institutions and to encourage improvements in service quality and growth of the industry. The Korean Institute of Genetic Testing Evaluation, responsible for managing and supervising the certification, assesses the accuracy of test results, propriety of testing processes, conformity of testing facilities and equipment to standards, and qualifications of testing personnel. This is to prevent any confusion that may arise due to inaccurate genetic testing.

The molecular genetic testing services performed at Macrogen Headquarters maintain A-grade certification (P-grade when including items not covered by health insurance). By providing customers with reliable results, Macrogen contributes to national health and progress in the national bioscience fields.

NGS Clinical Laboratory Certification

The NGS Clinical Laboratory Certification system, enforced by the Ministry of Food and Drug Safety since August 2016, is a system designed for the prompt availability of NGS-certified technologies in disease diagnostics and testing, including cancer genomic analyses and rare disease screening. Certifications are awarded based on a general evaluation of equipment, facilities, manpower, testing competencies, and quality control systems, and the reliability of test results.

Macrogen obtained NGS Clinical Laboratory Certification from the Ministry of Food and Drug Safety in April of 2017. With this certification, Macrogen is able to develop and provide various NGS-based clinical diagnostic testing services utilizing latest technologies such as cancer panels and liquid biopsies.